Summary & Overview
CPT 0400U: Genesys Carrier Panel, 145-Gene Carrier Screening
CPT code 0400U designates the Genesys Carrier Panel, a Proprietary Laboratory Analyses (PLA) test that screens 145 genes from blood or buccal swab specimens to identify carrier variants for rare inherited disorders, including cystic fibrosis. As a PLA code, 0400U applies exclusively to a single manufacturer's assay and signals a highly specific genomic service with implications for reproductive planning and genetic counseling. Nationally, such panels are increasingly relevant as carrier screening expands in preconception and prenatal care.
Key payers in scope include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose of the panel, expected service setting, and which major payers are discussed. The publication also covers benchmark considerations for billing and coverage, policy and coding updates affecting PLA codes, and clinical context for when a 145-gene carrier screen may be used.
This summary is intended for health plan analysts, billing managers, laboratory administrators, and clinicians seeking a national briefing on the coding and payer landscape for this specific genetic carrier screening test.
Billing Code Overview
CPT code 0400U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single, specific laboratory test: the Genesys Carrier Panel from Genesys Diagnostics Inc. The test uses a blood or buccal (cheek) swab specimen from a prospective parent to evaluate 145 genes for variants that may indicate carrier status for rare inherited disorders that could be passed on to a child, such as cystic fibrosis.
Service Type: Genetic carrier screening, laboratory test
Typical Site of Service: Clinical laboratory or outpatient specimen collection site (blood draw or buccal swab collection)
Clinical & Coding Specifications
Clinical Context
A 28-year-old individual planning a pregnancy presents to a reproductive genetics clinic for carrier screening. The patient provides a blood or buccal swab specimen for the Genesys Carrier Panel (0400U) from Genesys Diagnostics Inc. The panel analyzes 145 genes to identify pathogenic or likely pathogenic variants associated with autosomal recessive and X-linked disorders (for example, cystic fibrosis) that could be transmitted to offspring. Typical workflow: provider orders the proprietary test in the electronic medical record, obtains informed consent for genetic testing, collects a blood draw or buccal swab at the clinic or a collection center, ships the specimen to the performing laboratory, and receives a molecular genetics report with detected variants and classified results. Results are reviewed by the ordering clinician or genetic counselor to guide partner testing, reproductive planning, or referral to specialty care as needed. Typical site of service includes an outpatient genetics clinic, obstetrics/gynecology clinic, fertility clinic, or a commercial laboratory collection site.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when reporting only the professional interpretation component separate from the technical laboratory testing, if applicable under payer rules. |
TC | Technical component | Use when reporting only the technical component of the test (laboratory processing) separate from the professional interpretation. |
59 | Distinct procedural service | Data not available in the input. |
52 | Reduced services | Use if the laboratory procedure is partially performed or limited compared with the full protocol, per payer policy. |
53 | Discontinued procedure | Use when specimen processing was started but testing abandoned for clinical or technical reasons. |
78 | Unplanned return to OR | Not applicable to this lab-based service. |
80 | Assistant at surgery | Not applicable to this lab-based service. |
90 | Reference (outside) laboratory | Data not available in the input. |
QX | Ordering physician/other qualified healthcare professional attests to CLIA compliance | Use when specimen collection or order requires specific billing attestation or split/shared arrangements per payer rules. |
QY | Qualified nonphysician practitioner service | Use when a qualified nonphysician practitioner orders or furnishes the service, if required by payer. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Medical Genetics & Genomics | Physicians who order and interpret carrier screening and genetic test results. |
| 2080P0208X | Obstetrics & Gynecology | OB/GYNs who order preconception or prenatal carrier screening for patients. |
| 363L00000X | Clinical Laboratory | Laboratories performing the technical processing of molecular diagnostics. |
| 208D00000X | Reproductive Endocrinology/Infertility | Specialists who incorporate carrier screening into fertility planning. |
| 367A00000X | Genetic Counseling | Certified genetic counselors who review results and provide patient counseling. |
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Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0400U | Genesys Carrier Panel — Proprietary Laboratory Analyses for 145 genes | Primary test described; single-source PLA code for this carrier screening assay. |
81220 | CFTR (cystic fibrosis transmembrane conductance regulator) gene analysis, common variants | Often ordered historically or as targeted supplemental testing when CFTR-specific follow-up is needed after broad carrier panel findings. |
81335 | BRCA1 and BRCA2 full gene analysis | May be ordered separately when personal or family history indicates hereditary breast/ovarian cancer risk in addition to carrier screening. |
81479 | Unlisted molecular pathology procedure | Used rarely if a supplemental or novel molecular test related to carrier status is performed and no specific CPT exists. |
G0452 | Pharmacogenetic testing (example) | Pharmacogenetic tests are distinct but may be ordered in the broader reproductive genetics workup; included here as related ancillary molecular testing. |